IN THE HIGH COURT OF DELHI AT NEW DELHI
C. Hari Shankar, J.
Merck Sharp And Dohme Corp & Anr. - Appellants
Versus
Sms Pharmaceuticals Limited - Respondent
I.A. No. 7615 of 2021; C.S. (Comm) No. 463 of 2020
Decided On : 20-07-2021
The Court allowed the modification of the ex-parte ad interim order and permitted the defendant to export the API Sitagliptin to Chemo and Verben for research and development purposes. The Court held that the defendant was entitled to the benefit of Section 107A of the Patents Act, which permits the sale of patented products for research and development purposes. The Court also held that the defendant's exports were not for commercial purposes, as they were made to well-established entities engaged in research and development, located in Spain and Switzerland. The Court further held that the quantities of Sitagliptin Hydrochloride exported by the defendant in the past were much less than the quantities permitted to be exported by the Drug Control Authorities, clearly indicating that the exports were not for commercial exploitation.
Fact of the Case:
The plaintiff, Merck Sharp and Dohme Corporation (MSD), filed a suit against the defendant, SMS Pharmaceuticals Ltd. (SMS), for infringement of its patent for the drug Sitagliptin. MSD alleged that SMS was infringing the patent by advertising, selling, and exporting Sitagliptin Hydrochloride. SMS filed a written statement denying the allegations and asserting that it was engaged in research and development activities related to Sitagliptin. SMS also filed an application under Order XXXIX Rule 4 of the Code of Civil Procedure, 1908, seeking modification or vacation of the ex-parte ad interim injunction granted in favor of MSD.
Finding of the Court:
The Court held that the defendant was entitled to the benefit of Section 107A of the Patents Act, which permits the sale of patented products for research and development purposes. The Court also held that the defendant's exports were not for commercial purposes, as they were made to well-established entities engaged in research and development, located in Spain and Switzerland. The Court further held that the quantities of Sitagliptin Hydrochloride exported by the defendant in the past were much less than the quantities permitted to be exported by the Drug Control Authorities, clearly indicating that the exports were not for commercial exploitation.
Issues: Whether the defendant was entitled to the benefit of Section 107A of the Patents Act, which permits the sale of patented products for research and development purposes.
Ratio Decidendi: The Court held that the defendant was entitled to the benefit of Section 107A of the Patents Act, which permits the sale of patented products for research and development purposes. The Court also held that the defendant's exports were not for commercial purposes, as they were made to well-established entities engaged in research and development, located in Spain and Switzerland. The Court further held that the quantities of Sitagliptin Hydrochloride exported by the defendant in the past were much less than the quantities permitted to be exported by the Drug Control Authorities, clearly indicating that the exports were not for commercial exploitation.
Final Decision: The Court allowed the modification of the ex-parte ad interim order and permitted the defendant to export the API Sitagliptin to Chemo and Verben for research and development purposes.
JUDGMENT
C. Hari Shankar, J. - Ia 7615/2021 in CS (COMM) 463/2020
1. This application, by the defendant under Order XXXIX Rule 4 of the Code of Civil Procedure, 1908 (CPC), seeks vacation/modification of the ex-parte ad interim order, dated 21st October, 2020 passed by this Court in the present proceedings.
The controversy in issue and order dated 21st October, 2020
The Plaint
2. Plaintiff No. 1 - Merck Sharp and Dohme Corporation (who would, for the sake of convenience, be referred to, hereinafter, as "the plaintiff") has, by the present suit, sought injunction against infringement, by the defendant, of the plaintiff's Indian Patent No. 209816 ("IN'816", in short), whereby the plaintiff's invention, Sitagliptin, an anti-diabetic drug, stands patented.
3. The date of filing of the international application under the Patent Cooperation Treaty (PCT), for Sitagliptin, by the plaintiff, was 5th July, 2002. By operation of the explanation to Section 53(1) [1]of the Patents Act, 1970 ("the Patents Act"), therefore, the patent would expire on 5th July, 2022.
4. The plaint alleges that the defendant was infringing IN'816 of the plaintiff by advertising, for sale, Sitagliptin Hydrochloride in its list of Active Pharmaceutical Ingredients (APIs) and Analytical Standards. Reliance has been placed, in the plaint, on investigations stated to have been conducted by the plaintiff in September, 2020 which, according to the plaintiff, disclosed that the defendant was exploiting Sitagliptin for commercial use. For this, the plaint cites, by way of evidence, (i) the Product List of the defendant on its website, in which Sitagliptin is reflected under the categories "APIs" and "Analytical Standards", (ii) the fact that Sitagliptin does not figure among the products under the head "Pipeline" on the defendant's website, indicating that it was currently being offered for sale, (iii) the coverage, in the category of "APIs", on the defendant's website, of Sitagliptin Hydrochloride under the head "Current Product List", (iv) the listing, by the defendant, on its webpage, of five different isomers of Sitagliptin under the head "Analytical Standards", (v) the offering, for sale, of Sitagliptin API by the defendant through its business profile on India Mart, Linkedln, TradeIndia, JustDial, Pharma Compass and PharmaAdda, (vi) the "Pre-feasibility report" and "Final Environmental Assessment Report" submitted by the defendant to the Ministry of Environment, Forest and Climate Change and the "Executive Summary Report", submitted to the Andhra Pradesh Pollution Control Board in January, 2019, in all of which it was claimed that the manufacturing capacity of defendant, for Sitagliptin API would be 10 tonnes per month, after its expansion, and (vii) Export-Import data of the defendant, which reflected that, in 2017, 2018, 2019 and 2020, the defendant had exported Sitagliptin.
5. Additionally, the plaint also relies on personal enquiries stated to have been made, by the investigator engaged by the plaintiff with the defendant. Of these, the only enquiry which may be stated to have any relevance to effecting of sales by the defendant of Sitagliptin is by way of a call to one Mr. Chandra Shaker, Assistant General Manager of Marketing of the defendant, on 21st September, 2020. The plaint alleges that, from the said conversation, the investigator learnt that the defendant had been providing Sitagliptin API for sale in the domestic market and was willing to do so in future as well. It is further alleged that, vide a subsequent e-mail dated 21st September, 2020, Mr. Chandra Shaker provided the investigator the price quotation for Sitagliptin Phosphate API, which was 1 lakh per Kg.
6. On the basis of the aforesaid averments asserted in the plaint, this Court, vide order dated 21st October, 2020, on the very first date of hearing, observed and held thus:
"4. Grievance of the
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